1. Field of the Invention
The present invention relates generally to a device for endoluminal graft repair and more particularly to a balloon tipped catheter for the repair of endoluminal leaks in aortic or aorto-iliac, intra-aneurysmal endoluminal grafts.
2. Description of Related Art
Endovascular aneurysmal exclusion is an evolving method for treating arterial aneurysmal disease. Aneurysmal disease causes the weakening and radial distention of a segment of an artery. This arterial distention results in the development of an aneurysm, i.e., a bulging at the affected arterial segment.
An aneurysm is at risk of rupture resulting in extravasation of blood into, for example, the peritoneal cavity or into tissue surrounding the diseased artery. The goal of endovascular aneurysmal exclusion is to exclude from the interior of the aneurysm, i.e. aneurysmal sac, all blood flow, thereby reducing the risk of aneurysm rupture requiring invasive surgical intervention.
One procedure developed to accomplish this goal entails internally lining the affected artery with a biocompatible graft material. The graft material is configured in a generally tubular shape spanning across the aneurysm (intra-aneurysmal). The endoluminal graft is coupled to the artery and establishes a substantially fluid-tight seal above and below the distended aneurysmal segment at graft/artery interfaces.
Endoluminal grafts are positioned and deployed within the affected artery through insertion catheters by percutaneous procedures well know to those of skill in the art. Once deployed, the endoluminal graft provides an alternate conduit for blood flow and, at the same time, excludes the flow of blood into the aneurysmal sac. Endoluminal grafts provide a generally effective means to exclude blood flow from aneurysms.
However, important sequelae were reported in some cases of endoluminal graft placement. For example, incomplete seals at the graft/artery interfaces, graft defects, and retrograde blood flow from patent collateral arteries resulted in paragraft blood flow into the aneurysmal sac. See for example “Endoluminal leak as a Complication of Endoluminal Grafting of Abdominal Aortic Aneurysms: Classification, Incidence, Diagnosis, and Management” by Geoffrey H. White, et al., Journal of Endovascular Surgery 1997; 4:152–168. The flow of blood into the aneurysmal sac after endoluminal graft placement, a so-called endoluminal leak, reintroduces the risk of sac rupture.
As used herein, an endoluminal leak, sometimes called an endoleak, means a leak of blood into an aneurysmal sac associated with a defective or malfunctioning endoluminal graft. Endoluminal leaks are detected by use of well-known, conventional vascular imaging techniques such as angiography, computed tomographic (CT), and ultrasound scanning. As used herein, a micro-leak is a small endoleak not detectable by conventional vascular imaging techniques. Detection of micro-leaks requires specialized vascular imaging techniques such as radiopaque contrast fluid enhanced angiography and contrast enhanced CT scanning or color, duplex ultra-sound scanning. In addition, as used herein an endoluminal leak is distinguished from an aneurysmal leak, which generally refers to the flow of blood associated with a rupture of an aneurysm, from the aneurysm sac into the peritoneal cavity or surrounding tissue.
In the prior art, various methods and procedures were developed in attempts to stop endoluminal leaks through transluminal repair of the endoluminal graft. However, the methods and repair devices of the prior art generally were suitable only for gross endoluminal leaks detectable by conventional vascular imaging techniques. Prior art methods included surgical conversion of the endoluminal graft and total circumferential cuffing around the endoluminal graft with an annulus of sealant. Prior art methods did not address repair methods and devices suitable for the repair of micro-leaks detectable by specialized vascular imaging techniques.